|
Model Number 011014BBG |
Device Problem
Break (1069)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/16/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
No further information is available on the product at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.Device not returned.
|
|
Event Description
|
Aspen surgical received a report from the distributor indicating that a breakage in a vessel loop occurred during a procedure.The incident occurred at the end user.No injury/death was reported.This report was filed in our complaint handling system as number (b)(4).
|
|
Search Alerts/Recalls
|
|
|